Class I — Mercury Enterprises, Inc. dba Mercury Medical
| Recalling firm | Mercury Medical Enterprises, LLC |
|---|---|
| Registered facility | Mercury Medical Enterprises, LLC (the firm's only registered facility) |
| Classification | Class I |
| Status | Ongoing |
| Reason | Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step. |
| Product | Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support. |
| Quantity | 1,300 units |
| Distribution | US distribution to MI, FL, SC, PA, IN. International distribution to Albania. |
| Initiated | 2024-08-30 |
| Classified | 2024-10-02 |
| Recall number | Z-0004-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Mercury Enterprises, Inc. dba Mercury Medical (Z-0004-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95303/
Alerts for Mercury Medical Enterprises, LLC
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.